Robot-aided Proprioceptive Rehabilitation Training

University of Minnesota (UMN)

Status: Completed

Conditions: Stroke; Peripheral Sensory Neuropathy

Treatments: Behavioral: Proprioceptive training; Behavioral: Usual care

Study type: Interventional

Funder types: Other

Identifiers

NCT02565407

1505M72302

Details and patient eligibility

About

This study investigates the effect of a robot-aided 2-day proprioceptive training of the wrist on the proprioceptive and motor function of the wrist/hand complex in patients with proprioceptive impairment. The wrist proprioceptive training consists of active movement training with augmented haptic and vibro-tactile feedback provided by a patented wrist robotic system (US Serial No. 62/136,065). This study protocol can be applied to a variety of clinical and non-clinical populations. The purpose of this study is to obtain preliminary data on the effectiveness of the proprioceptive training in subjects with cortical stroke or peripheral sensory neuropathy.

Full description

This protocol seeks to improve proprioceptive-motor function. Proprioception refers to the perception of limb position or motion and the orientation of one's body in space. Numerous medical conditions with motor symptoms are also associated with proprioceptive loss, such as osteoarthritis, Parkinson's disease, peripheral sensory neuropathy, stroke, and developmental coordination disorder.

However, therapies to improve proprioceptive function in these populations are either non-existent or very limited in scope although it is established that proprioceptive impairments severely degrade motor function. The proposed protocol focuses on proprioception for fine motor function of the hand/wrist joint complex, because hand/wrist motor control is highly important for activities of daily living.

The specific aims are to determine if a 2-day wrist proprioceptive training:

1. improves limb position sense acuity,
2. improves the spatial precision of wrist/hand motor tasks,
3. increases the efficiency of performing such motor tasks,
4. is associated with neural changes in cortical processing as measured by short-latency somatosensory evoke potentials (SEP) and motor evoked potentials (MEP) using transcranial magnetic stimulation.

The study follows a crossover design with two arms and two groups. Time frame for the completion of the study is up to 7 days depending on the start day of the week (Monday through Friday). No testing will occur on the weekend.

Group 1 will have the following time frame: Day 1: pre-test (approx. 3 hrs.) and training intervention (approx. 30 min.). Day 2: training intervention (approx. 30 min.) and post-test 1 (approx. 3 hrs.). Days 3-6: Usual care (min. of 2 days required). Days 5-7: Post-test 2 (depending on the start day of the week, it is either Day 5,6, or 7).

Group 2 will have the following time frame: Day 1: pre-test 1 (approx. 3 hrs.). Days 2-4: Usual care (min. of 2 days required). Days 4-6: pre-test 2 (approx. 3 hrs.) and training intervention (approx. 30 min.). Days 5-7: Training intervention and post-test 1 (depending on the start day of the week, it is either Day 5,6, or 7).

Enrollment: 50 patients

Sex: All

Ages: 4 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

For all participants (both healthy and patient populations)

Inclusion Criteria:

1. wrist passive range of motion (ROM) more than 22.5° in flexion/extension
2. sense the vibro-tactile cues on either forearms in order to effectively receive the movement-related feedback
3. resist minimal resistance in gravity-eliminated position (score at least 2+/5 with the physical examination of manual muscle testing (Hislop, Avers, & Brown, 2013)) ) in all wrist movement directions.

Exclusion Criteria:

1. Regular intake of benzodiazepines.
2. Cognitive impairment: score ≥ 23 on Mini-mental state examination (Folstein, Robins & Helzer, 1983)
3. Depressive symptoms: score ≤ 19 on Beck depression inventory (Beck, Steer, & Carbin,1988).

Inclusion Criteria for Stroke Subjects

1. at least 3 months after stroke
2. whose age are between 30 to 75 years old.

Exclusion Criteria for Subjects undergoing the TMS procedure (Rossi, Hallett, Rossini, & Pascual-Leone, 2009)

• Has implanted metal in the body.
• Diagnosed with multiple sclerosis, major psychiatric conditions, epilepsy, history of seizures in the past 2 years, sleep deprivation, pregnancy, uncontrolled migraine, major traumatic head injury, severe heart disease, increased intracranial pressure, high consumption of alcohol, any conditions that predispose one to seizures
• Is currently taking any pro-epileptic medication (e.g. epileptogenic drugs such as tricyclic antidepressants)
• When no electromyography response can be elicited within the range of the TMS stimulator
• Pregnant at the time of data collection .

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

50 participants in 2 patient groups

Proprioceptive training

Experimental group

Description:

This arm will receive specialized robot-aided proprioceptive training of the wrist next to usual care.

Treatment:

Behavioral: Proprioceptive training

Usual care

Active Comparator group

Description:

This arm will receive what participants have been receiving from their healthcare providers. It may range from no treatment to various sessions of occupational and physical therapy at home, day rehabilitation, or outpatient visits.

Treatment:

Behavioral: Usual care